Cerebral Palsy (CP)BlendsNCT07341464
Acceptability and Tolerance Study of Bolus Tube Feed With Food Blends
A study testing Tube feed in people with Cerebral Palsy (CP) and Oncology, run by Société des Produits Nestlé (SPN) at 2 sites in United Kingdom.
Trial summary
This is a prospective acceptability study to evaluate the gastrointestinal tolerance and compliance of a bolus tube feed over a 28 -day period for up to 50 participants. The enteral bolus formula is for the dietary management of patients with short bowel syndrome; intractable malabsorption; preoperative preparation of… Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Cerebral Palsy (CP), Oncology
- What is being tested?
- Tube feed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 10 Dec 2025to 11 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients from 1 -15 years for children and 15 years and above for adults of requiring 1 or more bolus tube feed alongside their usual tube feed or home-made blended diet as part of their dietary management for disease related malnutrition.
- Patients well-established and stable on current enteral tube feed or home-made blended diet.
- Gastrostomy fed only.
- Willingly given, written, informed consent from patient/caregiver
Who cannot join
- Inability to comply with the study protocol, in the opinion of the investigator.
- Under 1 years of age
- Patients who have a nasogastric and jejunal feeding tubes
- Patients on total parenteral nutrition
- Known food allergies to any ingredients listed in appendix 1.
- Patients with significant renal or hepatic impairment
- Participation in another interventional study within 2 weeks of this study.
- Patients with known or suspected ileus or mechanical bowel obstruction
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sarah Durnan, PHD, BSc Nutrition Dietetics contact
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
Queen Medical Hospital Nutrition and Dietetics
Nottingham, NG7 2UH
Sarah Durnan, PHD Dietetics, 07812277811, s.durnan@nhs.net
James Evans, BSc Dietetics
- Recruiting
Dietetic Team 1st floor Kings Court 1, Charles Hastings Way,
Worcester, WR5 1JR
Martha Roos, BSc, +447717530359, martha.roos@nhs.net
About this study
Official title: Acceptability (Including Gastrointestinal Tolerance and Compliance) of a Paediatric and Adult Bolus Tube Feed With Food Blends
This is a prospective acceptability study to evaluate the gastrointestinal tolerance and compliance of a bolus tube feed over a 28 -day period for up to 50 participants.
The enteral bolus formula is for the dietary management of patients with short bowel syndrome; intractable malabsorption; preoperative preparation of undernourished patients; inflammatory bowel disease; total gastrectomy; dysphagia; bowel fistulae; feeding intolerances, developmental disabilities, and disease related malnutrition.
Read the detailed description
The study will collect data in 50 children and adults over a period of 28 days. Gastrointestinal tolerance will be collected over 7 days and formula intake will be over 28 days. A patient satisfaction questionnaire will be completed at the end of the study.
- Conditions
- Cerebral Palsy (CP), Oncology
- Being tested
- Tube feed
- Medical subject headings
- Cerebral Palsy, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tube feedDietary supplement
Dose intake and duration.
| Study group | Role | What they receive |
|---|---|---|
| Acceptability and Tolerance Study of bolus tube feed with food blends | Other | Arm one will act as their own controls Receives: Dietary Supplement: Tube feed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of Gastrointestinal tolerance
Severity of symptoms such as reflux, vomiting, constipation, diarrhoea as a four-point likert scale (none, mild, moderate, severe).
Measured: 7 days
Daily record of formula intake.
Measure of formula intake in mL.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start10 Dec 2025
- Primary completion10 Nov 2026 (estimated)
- Study completion11 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341464
- Sponsor's protocol ID
- BTB 001
- Other IDs
- IRAS ID 341165
- Acronym
- Blends
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability (Including Gastrointestinal Tolerance and Compliance) of a Paediatric and Adult Bolus Tube Feed With Food Blends
- ClinicalTrials.gov ID
- NCT07341464
- Acronym / sponsor ID
- Blends / BTB 001
- Conditions
- Cerebral Palsy (CP), Oncology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 10 Nov 2026 (estimated)
- Study completion
- 11 Nov 2026 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective acceptability study to evaluate the gastrointestinal tolerance and compliance of a bolus tube feed over a 28 -day period for up to 50 participants.
The enteral bolus formula is for the dietary management of patients with short bowel syndrome; intractable malabsorption; preoperative preparation of undernourished patients; inflammatory bowel disease; total gastrectomy; dysphagia; bowel fistulae; feeding intolerances, developmental disabilities, and disease related malnutrition.
Detailed description
The study will collect data in 50 children and adults over a period of 28 days. Gastrointestinal tolerance will be collected over 7 days and formula intake will be over 28 days. A patient satisfaction questionnaire will be completed at the end of the study.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acceptability and Tolerance Study of bolus tube feed with food blends | Other | Dietary Supplement: Tube feedArm one will act as their own controls |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients from 1 -15 years for children and 15 years and above for adults of requiring 1 or more bolus tube feed alongside their usual tube feed or home-made blended diet as part of their dietary management for disease related malnutrition.
- Patients well-established and stable on current enteral tube feed or home-made blended diet.
- Gastrostomy fed only.
- Willingly given, written, informed consent from patient/caregiver
Key exclusion criteria (8 listed)
- Inability to comply with the study protocol, in the opinion of the investigator.
- Under 1 years of age
- Patients who have a nasogastric and jejunal feeding tubes
- Patients on total parenteral nutrition
- Known food allergies to any ingredients listed in appendix 1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tube feedDose intake and duration. | Dietary supplement | Acceptability and Tolerance Study of bolus tube feed with food blends |
Primary outcome
Measure of Gastrointestinal tolerance
Time frame: 7 days
Severity of symptoms such as reflux, vomiting, constipation, diarrhoea as a four-point likert scale (none, mild, moderate, severe).
Daily record of formula intake.
Time frame: 28 days
Measure of formula intake in mL.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Durnan, PHD, BSc Nutrition Dietetics contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tube feed in people with Cerebral Palsy (CP) and Oncology, run by Société des Produits Nestlé (SPN) at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sharan Saduera, BSc (Hons) Dietetics (+447557170649, sharan.saduera@uk.nestle.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of Gastrointestinal tolerance (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.